Medicare Benefits Schedule Review Taskforce Report from the Obstetrics Clinical Committee

14.2.2Rationale 2

Item 71151 is used to detect leucocyte antigens and this testing is important in transplanting organs or tissue. The Committee noted that during 2014–15 there was variation in the utilisation of item 71151 across the states and territories, which can possibly be accounted for by public hospital laboratories in Qld and WA performing tissue typing onsite.

Genetic testing with HLA DQ2/DQ8 is useful in certain circumstances:

A negative test result excludes coeliac disease, as more than 99% of patients with coeliac disease carry one or other of the markers.

A positive test is not useful to diagnose coeliac disease because HLA DQ2/DQ8 is present in about 50% of the population. [2]

The Committee recognises that testing for coeliac disease-related HLA-DQ typing (i.e. for DQ2 and DQ8) is likely to be included in requests for item 71151 and therefore recommended that a new item be created for this indication.

This has been considered before by the Pathology Service Advisory Committee (PSAC). PSAC advised that item 71151 is at risk of inappropriate use by referrers, by possibly using a positive test result for HLA to imply the presence of possible coeliac disease; PSAC suggested restricting this item to promote appropriate use.

The Committee recognises there may be changes in clinical guidelines that may influence the requesting of this test, which could lead to increased testing.

As these are tests of a person’s DNA, the results should not change during their lifetime. However, testing a second time to confirm unexpected results may occasionally be required, or if results from previous testing are not available.

The Committee recognises that the current Schedule does not reflect current clinical practice and proposes that a new item be created for this test to be remunerated within the MBS (at the same fee for item 71151).

14.3Specific immunoglobulin E antibodies: item 71079

Table . Item introduction table for item 71079

Item	Long item descriptor	Schedule fee	Services FY 2014–15	Benefits FY 2014–15	Patient count	Services 5-year annual average growth
71079	Detection of specific immunoglobulin E (IgE) antibodies to single or multiple potential allergens, 1 test (Item is subject to rule 25)	$26.80	201,567	$4,615,660	191,701	7.3%

14.3.1Recommendation 3

Create a new item to capture multiple recombinant and purified component allergens.

Amend the item descriptor of item 71079 to add the word ‘extracted’.

The utilisation of the new item is to be monitored by the Department.

The Committee’s proposed changes to item 71079 are presented in the table below.

Table . Current and proposed item descriptors for item 71079 and new item

Item	Current item descriptor	Proposed item descriptor
71079	Detection of specific immunoglobulin E antibodies to single or multiple potential allergens, 1 test (Item is subject to rule 25)	Detection of specific immunoglobulin E (IgE) antibodies to single or multiple potential extracted allergens.
New item	—	Detection of specific immunoglobulin E (IgE) antibodies to single or multiple recombinant and purified component allergens for allergens. Explanatory note: This test is to be used in specific patient populations such as those who have food allergies, insect venom allergies and aeroallergies.

14.3.2Rationale 3

Item 71079 is an allergen-specific IgE antibody test used to screen for an allergy to a specific allergen, for example, the subcomponents of peanut such as Ara h 2. The Committee recognises the importance of allergen testing and considered the literature when making its recommendation for this item.

The clinical utility of recombinant and purified allergen testing was considered when the Committee was proposing recommendations for this item. Recombinant and purified allergen markers are considered to be more predictive of disease than previously available allergen extracts, hence the recommendation for introduction of the new item.

The issues regarding purified and recombinant allergens (sometimes referred to as component resolved diagnostics) are as follows:

In about the last 5 years a number of purified or recombinant allergens have been identified that can improve the performance of testing. Examples include Ara h 2, Ara h 8, Ara h 9 (these three for peanut), ‘alpha-gal’ (for meat allergy), and omega-gliadin (for exercise-induced wheat allergy)—the latter two are often used in workup of idiopathic anaphylaxis, a rare but serious consideration.

Recombinant allergen testing has greater clinical utility than routine allergy testing, in a small number of patients. The current item 71079 is used for both these newer allergen tests and the older less predictive allergen testing.

There are issues regarding the overuse of allergy testing (including allergen extracts), including:

The older / more established testing to allergen extracts are noted to be imperfect and inferior to skin prick testing when performed by a specialist allergist.

Access to allergist review is limited to metropolitan areas. Blood tests to allergen extracts can therefore be helpful for patients in regional and rural areas, and addresses the access gap.

The potential for overuse of blood tests for allergies is high. One solution would be to restrict to specialists. However, there are not enough allergists to review all these patients.

Many requests include an excessive number of allergens, with a diminishing yield from such ‘fishing trips’.

The test is difficult to restrict and there would be some patients, including some children, who would benefit from having multiple allergens tested on the one sample, although this is a very small group. This item could be restricted to a specialist only MBS number; nonetheless this would be a great challenge for the laboratory and not a solution for this item. Hence, the proposal to create a new item to capture the population—including patient populations who have food allergies, insect venom allergies and aeroallergies—that would require this test and that this new item be monitored to see requesting patterns.